Sat, 18 Nov 2017

Validated RP-HPLC Method for the Quantitation of Ganciclovir In Bulk and Capsule Dosage Form

Madhusudhana RG*, Jose Gnana Babu .C ,Tamizh Mani .T

1.Department of Pharmaceutical Analysis, Bharathi College of Pharmacy, BharathiNagara, K.M.Doddi, MaddurTaluk, Mandya District, Karnataka, India – 571 422


ABSTRACT

A simple, specific, accurate, precise and sensitive RP- HPLC method has been developed for the rapid estimation of Ganciclovir in bulk and its formulations. The chromatographic separation was carried on Grace smart RP-18 column (250 x 4.6 mm, 5 μm), using Methanol: Citrate buffer (0.05M) at PH-5.2 with KOH 70:30 (v/v) as mobile phase, at a flow rate of 1.0 ml/min.  The detection was carried out at 254 nm and drug eluted with a retention time of 2.982 min. Beer’s law was obeyed in the concentration range of 10-60μg/ml with correlation coefficient 0.999. The method has been validated according to ICH guidelines for specificity, linearity, accuracy, precision, robustness, ruggedness, LOD and LOQ. The method was found to be specific, accurate, and precise, robust, rugged and sensitive. The developed method was good linearity, novel, rapid for the estimation of Ganciclovir in bulk and capsule dosage form. Thus it can be employed for the routine analysis.

Keywords: Ganciclovir , RP-HPLC, Validation, Citrate buffer.


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